The Effect of Nasal Continuous Positive Airway Pressure Treatment on PTSD Symptoms. (PTSD)

The Effect of Nasal Continuous Positive Airway Pressure (Nasal CPAP) Treatment on Post Traumatic Stress Disorder (PTSD) Symptoms.

We hypothesize that prevention of Sleep Disordered Breathing among PTSD patients with nasal CPAP will result improve their anxiety, insomnia and alcohol craving (among those who use alcohol to control their symptoms).

Study Overview

• Status: Completed
• Conditions: Anxiety; Post Traumatic Stress Disorder; Nightmares; Unrefreshed Sleep
• Intervention / Treatment: Other: CPAP

Detailed Description

Design: This is a pilot study to study the effect of nasal CPAP on the symptoms of PTSD in veterans.

Recruitment Methods:

Veterans with PTSD will be recruited from the Northport VAMC PTSD unit. The ACOS/Mental Health will refer patients that meet inclusion criteria and do not have an impaired decision making capacity. Subjects will be screened for decision-making capacity by their treating psychiatrist as part of their clinical assessment upon admission to the PTSD unit.

Study Methods

This will be a prospective, randomized, controlled interventional trial:

1. Participants will undergo a routine clinical sleep study at the PTSD unit (using a portable polysomnographic recording unit). or undergo a routine clinical polysomnography to diagnose sleep disordered breathing

2. Participants who demonstrate SDB will be randomized into two groups based upon their body mass index

   1. Group A: BMI < 30 kg/m2
   2. Group B: BMI > 30 kg/m2 The reason for these two arms is to study the effect of nasal CPAP upon PTSD symptoms in veterans with a high prevalence of sleep apnea ( BMI above 30 kg/m2) and in veterans with predominantly snoring (BMI below 30 kg/m2).

   Each group will then be randomized into two sub-groups regarding treatment.

   1. Treatment group receives an automated CPAP unit to use during sleep for 6 weeks in conjunction with their usual care in the PTSD unit (psychotherapy).
   2. Control group receives the usual care that is provided in the PTSD unit for 6 weeks (change in medications will exclude the subject from the study), if any participant in the control group would like to try nasal CPAP, then he will be crossed over to use an automated CPAP unit during sleep for his second 6 weeks in the PTSD unit together with usual care.

3. All participants will fill out the following questionnaires at baseline and after 6 weeks. (Those in the control group who have been crossed-over to nasal CPAP will also fill out a set of questionnaire at 12 weeks).

   1. PTSD checklist-military version (anxiety)
   2. MASQ anxious arousal subscale (anxiety)
   3. Insomnia Severity Index (insomnia)
   4. The alcohol craving questionnaire (with an alcohol history during the intake) The changes in patient's reported outcomes will be compared before and after CPAP treatment and psychotherapy alone

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• United States
  • New York
    • Northport, New York, United States, 11768
      • PTSD unit at Northport VAMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

veterans admitted to PTSD unit at Northport VAMC

Description

Inclusion Criteria:

A. Admitted to PTSD unit at NVAMC and will remain in the unit for at least 12 weeks after initiation of study participation.

B. Found to have SDB by polysomnography

Exclusion Criteria:

1. Impaired Decision-Making Capacity, as determined by treating psychiatrist.
2. No sleep disordered breathing found by polysomnography
3. Unable/unwilling to use the nasal CPAP

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Effect of nasal Continuous Positive Airway Pressure (nasal CPAP) Treatment on Post Traumatic Stress Disorder (PTSD) Symptoms.	A comparison of the effectiveness of six weeks of nasal CPAP plus usual care to usual care alone at decreasing the symptoms of PTSD (anxiety, insomnia and alcohol craving) among veterans with PTSD and SDB	six weeks of nasal CPAP

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Effect of nasal Continuous Positive Airway Pressure (nasal CPAP) Treatment on Post Traumatic Stress Disorder (PTSD) Symptoms.	A comparison of the change in symptoms to the change in the total of sleep stage shifts during sleep for all patients with PTSD and SDB participating in the study.	6 weeks of nasal CPAP

Collaborators and Investigators

• Sponsor: Northport Veterans Affairs Medical Center
• Investigators: Principal Investigator: Mohammad Amin, MD, Northport VAMC

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: January 13, 2012
• First Submitted That Met QC Criteria: January 13, 2012
• First Posted (Estimate): January 19, 2012

Study Record Updates

• Last Update Posted (Estimate): September 25, 2014
• Last Update Submitted That Met QC Criteria: September 23, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 00383

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No